Cleared Traditional

K053083 - DATRIX CARDIO WIFI ELECTROCARDIOGRAPH

K053083 is an FDA 510(k) clearance for DATRIX CARDIO WIFI ELECTROCARDIOGRAPH, manufactured by Datrix. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K053083 · Datrix · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
28d
Days
Class 2
Risk

K053083 is an FDA 510(k) clearance for the DATRIX CARDIO WIFI ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Datrix (Escondido, US). The FDA issued a Cleared decision on November 30, 2005 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K053083

510(k) Number K053083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2005
Decision Date November 30, 2005
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 539
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K053083.
GALIX ECG PROFESSIONAL STATION
K051163 · Galix Biomedical Instrumentation, Inc. · Jan 2006
CARDIOSOFT PC ECG, USB VERSION
K052295 · Cardiosoft, L.P. · Jan 2006
READMYHEART, MODEL RMH2.0
K052303 · Dailycare Biomedical, Inc. · Dec 2005
CARDIOLINE AR 600, AR 1200, AR 2100
K051534 · Et Medical Devices Spa · Oct 2005
PHILIPS 12-LEAD ALGORITHM
K052049 · Philips Medical Systems · Aug 2005
READMYHEART, MODEL RMH3.0
K050620 · Dailycare Biomedical, Inc. · Jul 2005
K053083 · DATRIX CARDIO WIFI ELECTROCARDIOGRAPH
Download PDF FDA Summary Datrix